Ozarelix improved LUTS symptoms and urine flow over 28-week period QUEBEC CITY, May 23 /PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (TSX: AEZ; NASDAQ: AEZS), a global biopharmaceutical company focused on endocrine therapy and oncology, today announced that its partner Spectrum Pharmaceuticals (NASDAQ:SPPI) presented an abstract outlining detailed Phase 2 results for AEterna Zentaris' fourth-generation luteinizing hormone-releasing hormone (LHRH/GnRH) antagonist, ozarelix, in benign prostatic hyperplasia (BPH). Results indicate that ozarelix was well tolerated and demonstrated statistically significant as well as clinically meaningful efficacy in the treatment of lower urinary tract symptoms (LUTS) secondary to BPH. Results also showed no statistically significant impact on quality of life or erectile function. The abstract was presented yesterday afternoon at the American Urological Association (AUA) Annual Meeting being held this week at the Anaheim Convention Center in Anaheim, California. "We are encouraged by these data with ozarelix and look forward to seeing further results from the fully-enrolled Phase 2b trial, said David J. Mazzo, Ph.D., President and CEO of AEterna Zentaris. "With cetrorelix in an ongoing Phase 3 program and ozarelix completing a Phase 2b trial this year, we are fortunate to be leading the LHRH antagonist class with two very promising compounds for the treatment of BPH." Details The abstract #93629 (Poster #1552) titled, "The efficacy and safety of ozarelix, a novel GnRH antagonist in men with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH)" reviewed results of a randomized, double-blind, placebo-controlled, multi-center, dose-ranging Phase 2 trial in BPH. Ozarelix was given intramuscularly (IM) to men with moderate to severe LUTS due to BPH, to assess the compound's efficacy and safety. Eligible patients were treated with placebo for 4 weeks to establish baseline International Prostate Symptom Score (IPSS) and uroflow values. Afterwards, 144 patients meeting the inclusion criteria were randomly allocated to one of five treatment groups with the following dosage regimens: - Placebo; - Ozarelix 5 mg on Day 1 + 5 mg on Day 15; - Ozarelix 10 mg on Day 1 +10 mg on Day 15; - Ozarelix 15 mg on Day 1 + 15 mg on Day 15; or - Ozarelix 20 mg on Day 1 only. Patients were followed for 28 weeks. The primary efficacy endpoint was change in IPSS at week 12 compared to baseline. Secondary efficacy endpoints included changes in IPSS, Quality of Life (QoL), patients with >= 30% and >= 40% improvement in IPSS, uroflow values (Qmax), postvoid residual (PVR) urine volume and prostate volume. Safety analysis included changes in sexual function (IIEF-5), treatment of emergent adverse events (AEs), lab values (including testosterone (T), PSA) and vital signs. Mean age was 69.1 (range 52 - 85), IPSS 19.8, Qmax 9.7 mL/sec. and prostate size (cm(3)) 41.6 at baseline. Results The effects developed rapidly, with noticeable activity at four weeks from starting treatment, were maximal at 12-16 weeks, and persisted for the 6 month observation period. At week 12, all ozarelix-treated groups showed improvement with the greatest improvement in the 15 mg + 15 mg group. Change from baseline in IPSS was 8.6 (p